VKT PHARMA FDA Approval ANDA 215822

ANDA 215822

VKT PHARMA

FDA Drug Application

Application #215822

Application Sponsors

ANDA 215822VKT PHARMA

Marketing Status

Over-the-counter001
Over-the-counter002

Application Products

001TABLET;ORAL10MG0FAMOTIDINEFAMOTIDINE
002TABLET;ORAL20MG0FAMOTIDINEFAMOTIDINE

FDA Submissions

UNKNOWN; ORIG1AP2022-01-28STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

VKT PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215822
            [companyName] => VKT PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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